Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: one month after 3-dose infant series (at 7 months of age) ]

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after the toddler dose (at 13 to 16 months of age) ]

Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [ Time Frame: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) ]

Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: One month after the infant series (7 months of age) ]

Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ]

Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ]

Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series

Measure Description

No text entered.

Time Frame

one month after the infant series (7 months of age)

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample.

Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).

Measured Values

13vPnC

7vPnC

Number of Participants Analyzed
[units: participants]

94

108

Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
[units: titer]Geometric Mean ( 95% Confidence Interval )

Polio Type 1 (n=61,64)

483.72
( 352.52 to 663.75 )

479.79
( 361.79 to 636.26 )

Polio Type 2 (n=61,64)

368.26
( 250.75 to 540.84 )

403.45
( 249.90 to 551.96 )

Polio Type 3 (n=61,63)

914.01
( 638.80 to 1307.80 )

812.75
( 577.32 to 1144.18 )

Statistical Analysis 1 for Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series

Groups [1]

All groups

Ratio [2]

1.01

95% Confidence Interval

( 0.66 to 1.53 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Polio Type 1

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 2 for Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series

Groups [1]

All groups

Ratio [2]

0.91

95% Confidence Interval

( 0.56 to 1.49 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Polio Type 2

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 3 for Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series

Groups [1]

All groups

Ratio [2]

1.12

95% Confidence Interval

( 0.69 to 1.84 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Polio Type 3

[2]

Other relevant estimation information:

No text entered.

12. Secondary:

Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ]

Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: one month after the infant series (7 months of age) ]